Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Myl

FDA recall notice · announced August 19, 2015 · Mylan Institutional

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.

Reason for recall

Presence of Particulate Matter

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: a) 7801082, Exp. 07/15 and b) 7801421, Exp. 09/16
Quantity: a) 15,095 vials b) 300 vials
Status: Terminated
Products in this recall event:
- Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, N (D-1328-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.